FDA Plans to Use ISO 13485 for Medical Devices Regulation

(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.

The International Organization for Standardization’s (ISO) international standard, ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes, is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally.

The ISO technical committee (TC) 210 warmly welcomes the FDA’s planned adoption. ISO/TC 210, responsible for the quality management and corresponding general aspects for medical devices, is run by the American National Standards Institute (ANSI), ISO’s member in the United States.

“This announcement will take global harmonization of regulatory requirements in the medical devices sector to a next level,” says Wil Vargas of the Association for the Advancement of Medical Instrumentation (AAMI), and secretary of ISO/TC 210.

“This bold step by the FDA seems logical, considering the role of ISO 13485 as the foundation for the Medical Devices Single Audit Program (MDSAP), currently operated by Australia, Brazil, Canada, Japan, and the USA,” adds Peter Linders, chair of ISO/TC 210.